ORAL ARGUMENT SCHEDULED APRIL 10, 2012

NO. 11-5332

IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

R.J. REYNOLDS TOBACCO COMPANY, et al.,

Plaintiffs-Appellees,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants-Appellants.

On Appeal from the U.S. District Court

for the District of Columbia

BRIEF OF AMICI CURIAE AMERICAN ACADEMY OF PEDIATRICS,

AMERICAN CANCER SOCIETY, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN

LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, AMERICAN PUBLIC HEALTH ASSOCIATION,

CAMPAIGN FOR TOBACCO-FREE KIDS, CITIZENS’ COMMISSION TO PROTECT THE TRUTH, PUBLIC CITIZEN, AND THE TOBACCO CONTROL

LEGAL CONSORTIUM IN SUPPORT OF DEFENDANTS-APPELLANTS Gregory A. Beck Allison M. Zieve Public Citizen Litigation Group 1600 20th Street NW Washington, DC 20009 202-588-1000 Attorneys for Amici Curiae American Academy of Pediatrics, et al.

December 19, 2011

i

CERTIFICATE AS TO PARTIES, RULING, AND RELATED CASE S

Parties and Amici. Except for the following, all parties, intervenors, and

amici appearing before the district court and in this court are listed in the Brief for

Appellant: Citizens’ Commission to Protect the Truth and the Tobacco Control

Legal Consortium appear in this Court as amici curiae in support of the defendants-

appellants.

Rulings Under Review. References to the rulings at issue appear in the

Brief for Appellant.

Related Cases. In a case brought by several of the plaintiffs here, the district

court in Commonwealth Brands v. United States, 678 F. Supp. 2d 512 (W.D. Ky.

2010), cross-appeals pending sub nom. Discount Tobacco City & Lottery v. United

States, Nos. 10-5234 & 10-5235 (6th Cir.), rejected a First Amendment challenge

to the statutory provision at issue in this case.

/s/Gregory A. Beck

Gregory A. Beck

ii

CORPORATE DISCLOSURE STATEMENT

Amici American Academy of Pediatrics, American Cancer Society,

American Cancer Society Cancer Action Network, American Heart Association,

American Legacy Foundation, American Lung Association, American Medical

Association, American Public Health Association, Campaign for Tobacco-Free

Kids, Citizens’ Commission to Protect the Truth, Public Citizen, and the Tobacco

Control Legal Consortium are non-profit organizations that have no parents,

subsidiaries, or affiliates that have issued shares or debt securities to the public.

The general purpose of the amici organizations is to advocate for the public’s

health and for the protection of consumers. More detailed information about each

organization is set forth in the addendum to this brief.

/s/Gregory A. Beck Gregory A. Beck

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TABLE OF CONTENTS

CERTIFICATE AS TO PARTIES, RULING, AND RELATED CASES ................ i

CORPORATE DISCLOSURE STATEMENT ........................................................ ii

TABLE OF CONTENTS ......................................................................................... iii

TABLE OF AUTHORITIES .................................................................................... iv

GLOSSARY .............................................................................................................. ix

STATUTES AND REGULATIONS ........................................................................ ix

INTRODUCTION AND SUMMARY OF THE ARGUMENT ............................... 1

INTEREST OF AMICI .............................................................................................. 2

BACKGROUND ....................................................................................................... 3

ARGUMENT ............................................................................................................. 7

I. Overwhelming Evidence Supports the Revised Warning Requirements. .................................................................................................. 7

A. The Evidence Demonstrates that Large, Graphic Warnings Are Necessary to Adequately Inform Consumers of the Risks of Smoking. ................................................................................................ 7

B. The District Court’s Exclusive Focus on FDA Studies Ignores the Overwhelming Weight of Evidence Demonstrating the Warnings’ Effectiveness. .................................................................... 14

II. The District Court Failed to Give Weight to Congress’ Interest in More Effectively Informing Consumers About the Health Effects of Smoking. ........................................................................................................ 20

III. The Graphic Warnings Truthfully Inform Consumers of the Risks of Smoking. ........................................................................................................ 23

A. “Smoking can kill you.” ...................................................................... 26

iv

B. “Cigarettes are addictive.” ................................................................... 27

C. “Tobacco smoke can harm your children.” ......................................... 27

D. “Smoking during pregnancy can harm your baby.” ............................ 28

E. “Cigarettes cause cancer.” ................................................................... 29

F. “Cigarettes cause fatal lung disease.” ................................................. 29

G. “Cigarettes cause strokes and heart disease.” ..................................... 30

H. “Tobacco smoke causes fatal lung disease in nonsmokers.” .............. 31

I. “Quitting smoking now greatly reduces serious risks to your health.”................................................................................................. 31

CONCLUSION ........................................................................................................ 32

* Authorities upon which we chiefly rely are marked with asterisks.

iv

TABLE OF AUTHORITIES

Cases

Canada v. JTI-Macdonald Corp., [2007] S.C.C. 30 ................................................17

Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512 (2010) ...................................................................................... 6, 12, 13, 14, 24

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) ...................................................................................................................... 3

Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324 (2010)...........................................................................................................22

Nat’l Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d 104 (2d Cir. 2001) ..............................21

Pharm. Care Mgmt. Ass’n v. Rowe, 429 F.3d 294 (1st Cir. 2005) .....................................................................................................................21

United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D.D.C. 2006) ...................................................................................................4, 31

Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985) ............................................................................ 20, 22

Statutory and Regulatory Materials

Family Smoking Prevention and Tobacco Control Act (FSPTCA), Pub. L. No. 111-31 ................................................................... 1, 4, 24

16 C.F.R. § 1500.14 .................................................................................................24

16 C.F.R. § 255.5 .....................................................................................................21

16 C.F.R. § 316.1 .....................................................................................................21

16 C.F.R. § 455.2 .....................................................................................................21

21 C.F.R. § 201.57 ...................................................................................................21

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21 C.F.R. § 202.1(e) .................................................................................................24

FDA, Experimental Study of Graphic Cigarette Warning Labels (2010) ............................................................................................................. 18, 19

FDA, Required Warnings for Cigarette Packages and Advertisements, 75 Fed. Reg. 69,524 (2010) (notice of proposed rulemaking) .......................................................................... 2, 4, 5, 8, 26

FDA, Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011) (final rule) .............................................................. 3, 5, 10, 11, 15, 19, 20, 24, 25, 27, 32

Other Authorities

Abrams, Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am. J. Preventative Med. Supp. S351 (2010) ................................................................................................26

Borland, Impact of Graphic and Text Warnings on Cigarette Packs: Findings From Four Countries Over Five Years, 18 Tobacco Control 358 (2009) ......................................................................... 17, 23

Canadian Cancer Society, Cigarette Package Health Warnings (2010), available at http://tobaccofreecenter.org/files/pdfs/en/WL_status_report_en.pdf ................................................................................14

CDC, Health Effects of Secondhand Smoke, available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke/health_effects/index.htm ......................................................31

CDC, Preventing and Controlling Oral and Pharyngeal Cancer (August 1998), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00054567.htm ......................................................................29

CDC, Smoking and Tobacco Use: Fast Facts, available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm ....................................................................................................... 3

*

*

vi

CDC, Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses–United States, 2000-2004 (2008), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm ..................................................................................30

CDC, Tobacco-Related Mortality, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm .......................................... 30, 31

Cooley, Smoking Cessation Is Challenging Even for Patients Recovering from Lung Cancer Surgery With Curative Intent, 66 Lung Cancer 218 (Nov. 2009) .........................................................................27

Cummings, Are Smokers Adequately Informed about the Health Risks of Smoking and Medicinal Nicotine?, 6 Nicotine & Tobacco Res. 1 (2004) ..........................................................................................10

DiFranza, Effect of Maternal Cigarette Smoking on Pregnancy Complications and Sudden Infant Death Syndrome, 40 J. Family Practice 385 (1995) ..................................................................................28

Fathelrahman, Smokers’ Responses Toward Cigarette Pack Warning Labels in Predicting Quit Intention, Stage of Change, and Self-Efficacy, 11 Nicotine & Tobacco Res. 248 (2009) ....................................................................................................................17

Hammond, Effectiveness of Cigarette Warning Labels in Informing Smokers About the Risks of Smoking: Findings From the International Tobacco Control (ITC) Four Country Survey, 15 Tobacco Control iii19 (2006) .............................................................14

Hammond, Health Warning Messages on Tobacco Products: A Review, 20 Tobacco Control 327 (2011) ............................................. 9, 12, 16, 17

Hammond, Tobacco Packaging and Labeling: A Review of Evidence (2007), available at http://www.tobaccolabels.ca/factshee/article_ .................................................9, 13

Institute of Medicine, Ending the Tobacco Problem: A Blueprint for the Nation (2007), available at http://books.nap.edu/openbook.php?record_id=11795 ............ 6, 8, 9, 11, 12, 13, 16, 23, 24, 25, 28

*

*

vii

National Cancer Institute, The Role of the Media in Promoting and Reducing Tobacco Use (2008), available at http://www.cancercontrol.cancer.gov/tcrb/monographs/19/m19_complete_accessible.pdf ................................................................................ 4

President’s Cancer Panel, Promoting Healthy Lifestyles (2007), available at http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp07rpt/pcp07rpt.pdf ....................................................... 3, 26, 30

Surgeon General’s Report, How Tobacco Smoke Causes Disease (2010), available at http://www.surgeongeneral.gov/library/tobaccosmoke/report/full_report.pdf ........................................................30

Surgeon General’s Report, The Health Consequences of Involuntary Exposure to Tobacco Smoke 13-14 (2006), available at http://www.cdc.gov/tobacco/data_statistics/sgr/2006/index.htm .....................................................................................................28

Surgeon General’s Report, The Health Consequences of Smoking (2004), available at http://www.cdc.gov/tobacco/data_statistics/sgr/2004/index.htm .................................................... 27, 29, 30, 32

Surgeon General’s Report, Youth & Tobacco: Preventing Tobacco Use Among Young People (1994), available at http://profiles.nlm.nih.gov/ps/access/NNBCLQ.pdf .............................................. 9

U.S. Public Health Service, Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update (2008), available at http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf ..................................................................................25

Vardavas, Adolescents Perceived Effectiveness of the Proposed European Graphic Tobacco Warning Labels, 19 Eur. J. Pub. Health 212 (2009) .................................................................................................17

Walker, Smoking Relapse During the First Year After Treatment for Early-Stage Non-Small-Cell Lung Cancer, 15 Cancer Epidemiology Biomarkers & Prevention 2370 (2006) ............................27

Weinstein, Public Understanding of the Illnesses Caused by Cigarette Smoking, 6 Nicotine & Tobacco Res. 349 (2004)......................... 10, 29

*

*

viii

World Health Organization, Report on the Global Tobacco Epidemic 34 (2008), available at http://www.who.int/tobacco/mpower/2008/en/index.html ...................................................... 13, 14, 26

*

ix

GLOSSARY

CDC Centers for Disease Control and Prevention

FDA Food and Drug Administration

IOM Institute of Medicine

FSPTCA Family Smoking Prevention and Tobacco Control Act

WHO World Health Organization

STATUTES AND REGULATIONS

All applicable statutes and regulations are contained in the Brief for

Appellant.

1

INTRODUCTION AND SUMMARY OF THE ARGUMENT

The district court in this case granted a preliminary injunction against

enforcement of the enhanced warnings required by the Family Smoking Prevention

and Tobacco Control Act (FSPTCA), which, among other things, mandates that

cigarette packaging and advertising include “color graphics depicting the negative

health consequences of smoking.” Pub. L. No. 111-31, § 201(a). Amici curiae

submit this brief to highlight three points to which the district court failed to give

adequate weight in its decision to grant the injunction.

First, by limiting its review of the record to two FDA studies, the court

ignored all the evidence on which Congress relied when it passed the FSPTCA.

That evidence—which includes numerous consumer surveys, scientific studies,

and a consensus of the most respected national and international authorities in the

field—overwhelmingly establishes that existing warnings fail to adequately inform

the public of the risks of tobacco use, and that the large, graphic warnings required

by the FSPTCA are effective both at raising public awareness of the risks of

smoking and promoting public health by reducing tobacco use.

Second, the court gave no weight to Congress’s interest in ensuring that

consumers are effectively informed about the health consequences and addictive

impact of cigarettes. Federal and state regulations routinely require disclosure of

products’ threats to health and safety. Given that tobacco is the “leading cause of

2

preventable death and disease” in the United States, 75 Fed. Reg. 69,524, 69,534

(2010) (notice of proposed rulemaking), it is difficult to imagine any product for

which the Congress has a stronger interest in ensuring effective warnings.

Third, the district court enjoined all nine of the FDA’s graphic warnings on

the ground that they are not “factual,” but made no effort to examine the

truthfulness of any of the specific images depicted on the warnings. In fact, each of

the warnings illustrates a well-established consequence of using cigarettes. To the

extent that some of the images are disturbing, it is because they truthfully depict

the disturbing consequences of smoking.

INTEREST OF AMICI 1

Amici curiae are twelve nonprofit public health organizations, consumer

advocacy groups, and physicians’ associations that for decades have worked to

educate the public about and protect the public from the devastating health and

economic consequences of tobacco use. Amici have broad knowledge about the

history of tobacco regulation and the tobacco industry’s promotional techniques

and are particularly well qualified to assist the Court in understanding the

substantial public interest advanced by the tobacco warnings challenged here. A

1 This brief was not authored in whole or in part by counsel for a party. No

person or entity other than amicus curiae or its counsel made a monetary contribution to preparation or submission of this brief.

3

more detailed description of each organization is included in the appendix to this

brief. All parties have consented to the filing of this brief.

BACKGROUND

The FSPTCA responds to what the Supreme Court has described as “perhaps

the single most significant threat to public health in the United States.” FDA v.

Brown & Williamson Tobacco Corp., 529 U.S. 120, 161 (2000). An estimated

443,000 people in this country die each year from tobacco-related illnesses, such as

cancer, respiratory illnesses, and heart disease, making cigarettes the leading cause

of preventable death in the United States. 76 Fed. Reg. 36,628, 36,631 (June 22,

2011) (final rule); CDC, Smoking and Tobacco Use: Fast Facts.2 An

overwhelming majority of adult smokers started smoking before age 18. See

President’s Cancer Panel, Promoting Healthy Lifestyles 64 (2007) (President’s

Cancer Panel Report).3 And half of the children who become regular smokers will

die prematurely from a tobacco-related disease. Id.

Although for many years the tobacco industry feigned ignorance of the

addictive nature of its products, the FDA’s tobacco rulemaking in 1995 and 1996,

and the extensive findings of Judge Kessler in United States v. Philip Morris USA,

2Available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_

facts/index.htm. 3 Available at http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp07

rpt/pcp07rpt.pdf.

4

Inc., 449 F. Supp. 2d 1 (D.D.C. 2006), aff’d in relevant part, 566 F.3d 1095 (D.C.

Cir. 2009), found overwhelming evidence that the industry’s public statements

were lies. Id. at 852. Moreover, although the tobacco industry for decades denied

that it targeted youth in its advertising, the industry’s own documents show that,

early on, it understood the value of creating sophisticated advertising messages

directed toward young people and devoted “decades of research and development

of strategic plans designed to capture the youth market.” National Cancer Institute,

The Role of the Media in Promoting and Reducing Tobacco Use 157 (2008);4

Philip Morris, 449 F. Supp. 2d at 676.

In the FSPTCA, Congress adopted a comprehensive set of rules governing

the marketing of tobacco products. Plaintiffs in this case challenge only one aspect

of the law—its requirement that the FDA “issue regulations [for cigarette

packaging] that require color graphics depicting the negative health consequences

of smoking.” Pub. L. No. 111-31, § 201(b). In implementing that requirement, the

FDA consulted with “experts in the fields of health communications, marketing

research, graphic design, and advertising” to develop a set of proposed warnings.

75 Fed. Reg. at 69,534 (notice of proposed rulemaking). In November 2010, the

FDA published in the Federal Register and on the agency’s website 36 proposed

4 Available at http://www.cancercontrol.cancer.gov/tcrb/monographs/19/

m19_complete_accessible.pdf.

5

graphic warnings that “depict[] the negative health consequences of smoking” and

“illustrate[] the message conveyed by the accompanying textual warning

statement.” 76 Fed. Reg. at 36,636. The notice set forth much of the extensive

evidence on which Congress relied in passing the law, demonstrating both that

existing warnings have failed to adequately educate the public about the health

risks of tobacco and that larger, graphic warnings used in other countries have been

much more effective than text-only labels at informing consumers. 75 Fed. Reg. at

69,529-34. That evidence includes numerous consumer surveys, scientific studies,

and the conclusions of the Surgeon General, the President’s Cancer Panel, the

National Cancer Institute, the Institute of Medicine, and the World Health

Organization.

The agency received more than 1,700 comments “from cigarette

manufacturers, retailers and distributors, industry associations, health

professionals, public health or other advocacy groups, academics, State and local

public health agencies, medical organizations, individual consumers, and other

submitters.” 76 Fed. Reg. at 36,629. Based on these comments and on the agency’s

own research on the effectiveness of the proposed images, the FDA selected nine

graphic warnings to illustrate each of the nine textual warnings written by

Congress. Id. at 36,636.

6

Before the FDA had published its final rule, however, several tobacco

companies—including many of the plaintiffs here—sued the FDA in the U.S.

District Court for the Western District of Kentucky to enjoin the warning

requirements and other provisions of the Act. In Commonwealth Brands, Inc. v.

United States, 678 F. Supp. 2d 512, 528-32 (2010), the court rejected the plaintiffs’

challenge to the warnings and granted summary judgment to the government on

that issue. The court found “Congress’s decision to revise the content and format

of the tobacco warnings justified” by evidence that the pre-FSPTCA warnings

were largely ignored by consumers and “fail[ed] to convey relevant information in

an effective way.” Id. at 530-31 (quoting Institute of Medicine, Ending the

Tobacco Problem: A Blueprint for the Nation 291 (2007) (IOM Report)).5 The

court also rejected the plaintiffs’ argument that “the new warnings are too large

and too prominent,” noting the weight of authority behind similar warnings. Id. at

531. The decision is on appeal to the Sixth Circuit.

Plaintiffs filed this second challenge to the warning requirements soon after

the FDA announced its final rule, seeking injunctive relief and a declaratory

judgment that the warnings infringe their First Amendment rights. The district

court granted a preliminary injunction, concluding that the warnings constitute

“compelled commercial speech.” App. 27. The court rejected the government’s

5 Available at http://books.nap.edu/openbook.php?record_id=11795.

7

argument that the warnings present important factual information about the health

risks of smoking, holding instead that the warnings are not “purely factual and

uncontroversial” because they are “unquestionably designed to evoke emotion.” Id.

at 28. The court subjected the warnings to a strict-scrutiny standard of review,

concluding that the government had failed to prove that the warnings were

narrowly tailored to advance a compelling government interest. Id. at 30-35.

ARGUMENT

I. Overwhelming Evidence Supports the Revised Warning Requirements.

In concluding that the government had not demonstrated that graphic

warnings are necessary to achieving Congress’s goal, the district court ignored the

entirety of the record on which Congress relied in enacting the warning

requirement. The record as a whole, along with Congress’s findings and years of

experience documenting the effectiveness of large, graphic warnings, amply

support Congress’s conclusion that current warnings have failed to adequately

inform consumers, and that requiring larger, graphic warnings is necessary to

accomplishing that goal.

A. The Evidence Demonstrates that Large, Graphic Warnings Are Necessary to Adequately Inform Consumers of the Risks of Smoking.

For almost fifty years, Congress and the federal government have attempted

to better inform the American public about the health consequences of cigarette

smoking—adopting three prior sets of warning labels, issuing repeated reports on

8

the health consequences of smoking, and seeking to curtail the industry’s deceptive

health claims. Despite these efforts, Congress and the FDA found that the public

remains misinformed about the risks of smoking. As the FDA concluded,

“[r]esearch has repeatedly illustrated that the current warnings … frequently go

unnoticed or fail to convey relevant information regarding health risks.” 75 Fed.

Reg. at 69,529.

1. Congress’s decision to require large, graphic warning labels was based on

decades of experience with the failure of less prominent, textual warnings to

accomplish their purpose. The United States first began requiring cigarette warning

labels in 1966 and has revised the warnings twice since then. Id. at 69,529-30. The

existing warnings—which were last updated in 1984—are small and easy to

ignore. Id. at 69,530. These warnings occupy only half of the narrow side of

cigarette packages and are not visible when the packages are on display:

As a result, the warnings go largely unnoticed by consumers. IOM Report at 291.

Studies show that “small text warnings are associated with low levels of

awareness and poor recall.” Hammond, Health Warning Messages on Tobacco

9

Products: A Review, 20 Tobacco Control 327, 329 (2011). In one study on how

well students could remember the contents of cigarette packaging, only 7% of

students in the United States mentioned health warnings. Hammond, Tobacco

Packaging and Labeling: A Review of Evidence 5 (2007).6 At the same time, in

Canada, where a warning appears on the front of the package, 83% of students

mentioned the warnings. Id.

Reviewing the available evidence, the Surgeon General concluded in 1994

that empirical studies “consistently indicate that the Surgeon General’s warnings

are given little attention or consideration by viewers.” Surgeon General’s Report,

Youth & Tobacco: Preventing Tobacco Use Among Young People 168 (1994).7

Similarly, the Institute of Medicine concluded that text warnings in the United

States receive little notice by smokers. IOM Report at 290-91. The Institute found

that existing warning labels have been “woefully deficient” at informing

consumers of the consequences of smoking, and recommended the adoption of

large, graphic warning labels. Id. at 291.

2. Extensive research and the FDA’s findings demonstrate that—despite the

existing warnings—tobacco users in the United States fail to appreciate the extent

of the health risks associated with tobacco use and, in fact, greatly underestimate

6 Available at http://www.tobaccolabels.ca/factshee/article_. 7 Available at http://profiles.nlm.nih.gov/ps/access/NNBCLQ.pdf.

10

their personal risk. See Weinstein, Public Understanding of the Illnesses Caused by

Cigarette Smoking, 6 Nicotine & Tobacco Res. 349, 349 (2004) (“[E]ven though

people recognize that smoking can lead to adverse health consequences, they do

not have even a basic understanding of the nature and severity of these

consequences.”); Cummings, Are Smokers Adequately Informed about the Health

Risks of Smoking and Medicinal Nicotine?, 6 Nicotine & Tobacco Res. 1, 1 (2004)

(finding that “smokers are misinformed about many aspects of the cigarettes they

smoke … and that they want more information about ways to reduce their health

risks”).

Although smokers generally understand that smoking can cause lung cancer,

they are less likely to understand the degree of risk. One study found that more

than a quarter of smokers did not believe that smoking increased the risk of getting

cancer “a lot.” 76 Fed. Reg. at 36,632; see Weinstein, 6 Nicotine & Tobacco Res.

at 349 (finding that “lung cancer was the only illness that could be identified by a

clear majority of respondents,” and that—even as to lung cancer—people

underestimated the fatality rate and overestimated length of life). Smokers are also

much less aware of the risk of different forms of cancer and of other health risks

caused by tobacco use. 76 Fed. Reg. at 36,632. Indeed, one survey found that

“more than half of the respondents were unable to name a smoking-related illness

other than lung cancer.” Id. Up to a third of smokers also believe that activities like

11

exercise or taking vitamins can “undo” most of the negative effects of smoking. Id.

Knowledge about the health risks of smoking is particularly low in some

demographic groups, including low-income Americans and those with fewer years

of education. Id. Based on this evidence, the FDA concluded that, “[w]hile most

smokers understand that smoking poses certain statistical risks to their health,

many fail to appreciate the severity and magnitude of those risks.” Id.

Even smokers who can accurately identify statistical risks of smoking are

unlikely to appreciate their own risk of disease. Id. One study found that only 40%

of smokers believed they had a higher-than-average risk of cancer, and only 29%

believed they had a higher-than-average risk of heart disease. Id. Among smokers

who smoke 40 or more cigarettes per day, less than half believed they were at

increased risk of those diseases. Id. Smokers are also more than twice as likely as

nonsmokers to doubt that tobacco use, even for as long as 30 to 40 years, would

cause death. IOM Report at 90. And the FDA found that smokers’ understanding

of their personal risk “may be too abstract to be thought of at the time of purchase”

when warnings fail “to make the relevant risks salient.” 76 Fed. Reg. at 36,633.

These problems are particularly serious among youth. Id. at 36,632. The

Institute of Medicine explained that “adolescents misperceive the magnitude of

smoking harms and the addictive properties of tobacco and fail to appreciate the

long-term dangers of smoking, especially when they apply the dangers to their own

12

behavior.” IOM Report at 93. Although adolescents overestimate the risks of lung

cancer, they underestimate the danger of addiction, the likelihood that they will

suffer tobacco-related disease, and the degree to which smoking can shorten their

lives. Id. at 89-90.

3. In contrast to existing warnings, the effectiveness of large, graphic

warnings is extensively documented in independent research. A recent review of

ninety-four separate studies on tobacco warnings concluded that “the impact of

health warnings depends on their size and design.” Hammond, 20 Tobacco Control

at 327. “[W]hereas obscure text-only warnings appear to have little impact,

prominent health warnings on the face of packages serve as a prominent source of

health information for smokers and non-smokers, can increase health knowledge

and perceptions of risk and can promote smoking cessation.” Id. As the court in

Commonwealth Brands recently held in rejecting a tobacco-industry challenge to

the FSPTCA’s warning requirement, “the government’s goal is not to stigmatize

tobacco products on the industry’s dime; the goal is to ensure that the health risk

message is actually seen by consumers in the first instance.” 678 F. Supp. 2d at

530.

Experts agree that package warnings are more effective—particularly among

youth—when they involve imagery. “[P]ictures with graphic depictions of disease

and other negative images [have] greater impact than words alone … .” World

13

Health Organization, Report on the Global Tobacco Epidemic 34 (2008) (WHO

Report);8 see IOM Report at 290-96. Images more effectively draw attention to the

message and make it more memorable, while prompting consumers to think about

the consequences of smoking. See Hammond, Tobacco Packaging and Labeling at

10. One study showed that 90% of young people surveyed thought that picture

warnings were informative and made smoking seem less attractive. Id. at 8.

Another study found that children are more likely to consider and talk about

picture warnings on cigarette packaging than non-picture warnings. Id. at 9.

Graphic warnings are also important for communicating with consumers with low

levels of education, given evidence that those consumers “are less likely to recall

health information in text-based messages.” IOM Report at 295; see also id. at C-3

(noting that current warnings “require a college reading level” and thus “may be

inappropriate for youth and Americans with poor reading abilities”).

In adopting larger, graphic warnings, the United States followed a growing

consensus among nations that graphic warnings covering a substantial portion of

the front and back panels of cigarette packages are the most effective means of

informing consumers about the risks of smoking. Commonwealth Brands, 678 F.

Supp. 2d at 531. At least 39 countries require graphics on cigarette packaging,

including Canada, Brazil, Great Britain, Australia, and Switzerland. See Canadian

8 Available at http://www.who.int/tobacco/mpower/2008/en/index.html.

14

Cancer Society, Cigarette Package Health Warnings 3 (2010).9 Thirty-two

countries require at least half of the front and back panels of a cigarette container

to be used for warnings. Id. at 4. There is strong evidence that these warnings have

been effective both in educating consumers and in reducing smoking. See

Hammond, Effectiveness of Cigarette Warning Labels in Informing Smokers About

the Risks of Smoking: Findings From the International Tobacco Control (ITC)

Four Country Survey, 15 Tobacco Control iii19 (2006) (concluding that smokers

“exhibited significant gaps in their knowledge of the risks of smoking,” but that

smokers in countries with larger, graphic warnings had more knowledge of the

risks). Citing the success of warnings in these countries, the World Health

Organization recommends that warnings, including both pictures and words,

“should cover at least half of the packs’ main display areas and feature mandated

descriptions of harmful health effects.” WHO Report at 34; see also

Commonwealth Brands, 678 F. Supp. 2d at 531.

B. The District Court’s Exclusive Focus on FDA Studies Ignores the Overwhelming Weight of Evidence Demonstrating the Warnings’ Effectiveness.

The district court ignored the entirety of the record on which Congress relied

in adopting the new warning requirements. Instead, it singled out for criticism a

9 Available at http://tobaccofreecenter.org/files/pdfs/en/WL_status_report_

en.pdf.

15

regulatory-impact analysis and consumer study conducted by the FDA to help it

choose specific images to illustrate the textual warnings. But those studies were

conducted after Congress had already adopted the graphic warning requirement,

were not designed to assess whether the warnings are necessary, and do not

undermine the overwhelming weight of evidence supporting the effectiveness of

graphic warnings.

1. The district court concluded that the FDA’s regulatory-impact analysis

failed to establish that tobacco use in Canada declined after that country adopted

graphic warnings similar to those required by the FSPTCA. App. 19-20 & nn.9-10.

The agency’s analysis, however, was never designed to carry that burden. As the

FDA explained, its regulatory-impact analysis was subject to a “large uncertainty”

because it was based on “very small data sets” and depended on unmeasurable

differences between the “social and policy climate of the U.S. and Canada.” 76

Fed. Reg. at 36,721. Although, based on this limited data, the agency could “not

reject, in a statistical sense, the possibility that the rule will not change the U.S.

smoking rate,” it also could not reject the possibility that the rule would lead to

significant reductions in tobacco use and thus savings to the American public. Id.

The agency’s best estimate was that the warnings would cause 213,000 people to

quit smoking by 2013. Id.

16

Moreover, the FDA’s difficulty in quantifying the impact of the rule on

smoking prevalence does not undermine the other extensive evidence—set forth in

detail in the FDA’s notice of proposed rulemaking and final rule, but ignored by

the district court—that Canada’s warnings were effective both in substantially

reducing tobacco use and in communicating information to consumers. Studies

show that Canadian smokers who have read, thought about, and discussed graphic

labels were more likely to have quit, tried to quit, or reduced their smoking. IOM

Report at 295. One-fifth of Canadian smokers said that they smoked less, and one-

third said they were more likely to quit, because of the warnings. Id. Former

smokers also identified the pictorial warnings as important factors in quitting and

in subsequently remaining nonsmokers. Id.

There is also strong evidence that pictorial warnings in Canada have been

effective in deterring children from taking up smoking. Approximately six years

after the introduction of pictorial warnings, more than 90% of surveyed Canadian

youth agreed that pictorial warnings on Canadian cigarette packages had provided

them with important information about the health consequences of smoking and

made smoking seem less attractive. Hammond, 20 Tobacco Control at 330. Given

this and other evidence, the Canadian Supreme Court unanimously rejected a

challenge to the warnings by tobacco companies there, concluding that “[t]he

17

benefits flowing from the larger warnings are clear.” Canada v. JTI-Macdonald

Corp., [2007] S.C.C. 30 ¶ 139.

Studies of warnings outside Canada back up this conclusion. See generally

Hammond, 20 Tobacco Control 327. For example, a study of graphic warnings

introduced in Australia in 2006 found that the “self-reported impact” of tobacco

use “increased significantly” after the country adopted the enhanced warnings.

Borland, Impact of Graphic and Text Warnings on Cigarette Packs: Findings

From Four Countries Over Five Years, 18 Tobacco Control 358, 359-60 (2009).

The study concluded that Australia’s experience “strengthened the existing

evidence that reactions to warnings predict subsequent quitting.” Id. at 359. Other

studies have found similar effects of graphic warnings in other countries. See, e.g.,

Fathelrahman, Smokers’ Responses Toward Cigarette Pack Warning Labels in

Predicting Quit Intention, Stage of Change, and Self-Efficacy, 11 Nicotine &

Tobacco Res. 248 (2009) (Malaysia); Vardavas, Adolescents Perceived

Effectiveness of the Proposed European Graphic Tobacco Warning Labels, 19 Eur.

J. Pub. Health 212 (2009) (European Union).

2. The district court also singled out the FDA’s consumer research for

criticism, concluding that it failed to demonstrate “whether any singular graphic

warning was effective on its own terms.” App. 32. Like the agency’s regulatory-

impact analysis, however, its consumer research was not designed to provide

18

independent proof of the effectiveness of graphic warnings, which had already

been demonstrated by a large number of independent studies. Rather, the purpose

of the study was to test the “relative efficacy” of each of the 36 graphic warnings

proposed in the agency’s notice of proposed rulemaking. FDA, Experimental Study

of Graphic Cigarette Warning Labels 1-1 (2010) (FDA Study) (emphasis added).

The study tested the effectiveness of each proposed graphic by exposing

participants to a single viewing of one of the warnings and measuring both the

participants’ immediate reaction and their ability to recall the warning’s content

later. Id. at 1-3. Such measurements are relevant in evaluating the relative

effectiveness of warnings because evidence demonstrates that a warning’s effect

on long-term changes in knowledge and behavior depends on the viewer’s

“immediate emotional and cognitive reactions” to the warning. Id. at 4-1. As the

study’s authors explained, a strong immediate reaction “enhances recall and

processing of the health warning, which helps ensure that the warning is better

processed, understood, and remembered.” Id. at 1-2. These “immediate responses”

lead to “later recall of the message and changes in knowledge, attitudes, and beliefs

related to the dangers of tobacco use and exposure to secondhand smoke,” and

“eventually … to changes in intentions to quit/start smoking.” Id.

The study concluded that “[m]ost of the [proposed] warning images elicited

strong emotional and cognitive responses compared with controls,” and that

19

participants’ recall of the images was strong—exceeding 70% even one week after

viewing. Id. at 4-1, 4-2. Moreover, the images adopted by the FDA in its final rule

were generally more likely than other proposed images to be memorable and to

make an impact on the viewer. Of the graphics proposed to illustrate the warning

“cigarettes are addictive,” for example, the study found that the FDA’s chosen

image of a man blowing smoke from a tracheostomy hole was most likely to elicit

a strong reaction from the viewer. Id. at 3-2, 3-4, 4-2.

Although these findings suggest that the FDA’s chosen warnings are likely

to lead to long-term effects on consumers’ attitudes and behavior, id. at 4-1, the

study was not intended to detect or measure such long-term effects directly. The

effectiveness of graphic warnings on tobacco packaging comes not from a single

exposure, but from repeated exposure at the moment when the viewer is deciding

whether to purchase or use tobacco. As the FDA explained, “pack-a-day smokers

are potentially exposed to warnings more than 7,000 times per year.” 76 Fed. Reg.

at 36,631. But changes in behavior “are unlikely to be immediate or short-term,”

FDA Study at 1-2, and the study’s design did “not allow for assessment of the

effect [of] repetitive viewing of the graphic warning labels.” Id. at 4-5.

Even given these limitations, the study found that, after only a single

viewing, several of the images had a significant impact on beliefs about the health

risks of smoking. Id. at 4-3. And although the study—as expected—did not find

20

“strong evidence” that the warnings increased subjects’ intention to quit smoking

after a single viewing, several of the images showed a statistically significant

impact on the intention to quit in at least one sample group. Id. Far from casting

doubt on the graphic warning requirement, the warnings’ ability to create any

measurable effect on smokers’ beliefs and intention to quit after only one viewing

powerfully demonstrates the warnings’ effectiveness.

II. The District Court Failed to Give Weight to Congress’ Interest in More Effectively Informing Consumers About the Health Effects of Smoking.

A. Even if the evidence that the revised warnings will lead to a reduction in

smoking were not as compelling as it is, the First Amendment would not prohibit

the government from requiring tobacco companies to more effectively inform

consumers about the risk of serious injury and death caused by their products.

Because “the extension of First Amendment protection to commercial speech is

justified principally by the value to consumers of the information such speech

provides, … the First Amendment interests implicated by disclosure requirements

are substantially weaker than those at stake when speech is actually suppressed.”

Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S.

626, 651 & n.4 (1985). Unlike prohibitions on speech, disclosure requirements

have no potential to “offend the core First Amendment values of promoting

efficient exchange of information.” Nat’l Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d

21

104, 113-14 (2d Cir. 2001). Indeed, such “disclosure furthers, rather than hinders

the First Amendment goal of the discovery of truth.” Id. at 114.

Numerous other laws require advertisers to include health and safety

warnings that are necessary for consumers to understand the risks they will

undertake if they heed the advertiser’s commercial message. For example, the FDA

mandates warnings on drug labels, including prominent “black box” warnings that

emphasize particular hazards. 21 C.F.R. § 201.57. Likewise, the Federal Trade

Commission mandates disclosures by automobile dealers of warranty information

in “Buyers’ Guides” on used cars, 16 C.F.R. § 455.2 (specifying format and

content of form required to be displayed on window of used car offered for sale to

consumers), disclosures in connection with promotion of franchising opportunities,

id. § 316.1, and disclosures of relationships between an endorser and a seller of a

product, id. § 255.5. “There are literally thousands of similar regulations on the

books, such as product labeling laws, environmental spill reporting, accident

reports by common carriers, [and] SEC reporting as to corporate losses.” Pharm.

Care Mgmt. Ass’n v. Rowe, 429 F.3d 294, 316 (1st Cir. 2005); see also Sorrell, 272

F.3d 104 (upholding a Vermont law requiring manufacturers to inform consumers

that products contain mercury and should be recycled or disposed of as hazardous

waste).

22

The First Amendment does not prohibit the government from compelling

such warnings. In Zauderer, for example, the Supreme Court upheld the

constitutionality of a state bar disciplinary rule requiring attorneys who advertised

contingent-fee representation to disclose that clients may still have to bear certain

costs. See 471 U.S. at 633. Notably, the Court did not require the state to show that

the disclosures would affect consumers’ decisions. Rather, the Court held the

disclosure to be justified because the average consumer might not understand the

difference between fees and costs. Id. Similarly, the Court in Milavetz, Gallop &

Milavetz, P.A. v. United States upheld a federal law requiring “debt relief

agencies” to disclose, among other things, that their assistance “may involve

bankruptcy relief.” 130 S. Ct. 1324, 1339 (2010). Again, the Court did not require

evidence that the disclosure would change consumer behavior. Noting that “the

less exacting scrutiny described in Zauderer governs” when “the challenged

provisions impose a disclosure requirement rather than an affirmative limitation on

speech,” the Court held the government’s burden to be satisfied by “[e]vidence in

the congressional record demonstrating a pattern of advertisements that hold out

the promise of debt relief without alerting consumers to its potential cost.” Id.

B. The district court here discounted the government’s “information goal”

on the ground that, “[a]s best as [it could] discern … the Government’s primary

purpose is not, as it claims, merely to inform.” App. 31-32. In refusing to credit the

23

government’s interest, the court failed to consider the powerful evidence

demonstrating that graphic warnings are highly effective at increasing public

awareness about the risks of tobacco. In studies of Canadian smokers,

“approximately 95 percent of youth smokers and 75 percent of adult smokers

report that the pictorial warnings have been effective in providing them with

important health information,” and more than half “reported that the pictorial

warnings have made them more likely to think about the health risks of smoking.”

IOM Report at 294. Moreover, in a recent study of more than 8,000 smokers from

Canada, Australia, the United States, and the United Kingdom over a five-year

period, 85% of Canadian respondents cited packages as a source of health

information, compared to only 47% of U.S. smokers. Borland, 18 Tobacco Control

at 358. Like the required disclosure in Zauderer, the warnings thus ensure that

consumers are better informed about the products they are purchasing, thereby

serving the same constitutional purpose as does the commercial speech doctrine

itself.

III. The Graphic Warnings Truthfully Inform Consumers of the Risks of Smoking.

The district court did not question the accuracy of the new textual warnings

required by Congress, which truthfully state, among other things, that cigarettes are

addictive; that they cause cancer, fatal lung disease, strokes, and heart disease; and

that “[q]uitting smoking now greatly reduces serious threats to your health.”

24

FSPTCA § 201(a). As Commonwealth Brands held, these statements are “objective

and [have] not been controversial for many decades.” 678 F. Supp. 2d at 531-32.

Instead, the court held that the graphic images accompanying the textual warnings

“cross the line from information to advocacy” because they are “designed to evoke

emotion.” App. 35 n.28. Yet the specific graphic warnings chosen by the FDA—

like the textual warnings they accompany—truthfully convey the health

consequences of smoking. Each image “illustrate[s] the message conveyed by the

accompanying textual warning statement” by depicting smoking risks that are

“well-established in the scientific literature.” 76 Fed. Reg. at 36,636, 36,641.

The First Amendment does not prohibit mandatory warnings that may make

consumers uncomfortable. The requirement that drug companies disclose side

effects in prescription-drug advertisements, for example, does not violate the First

Amendment because it requires discussion of conditions that may disgust some

consumers, see 21 C.F.R. § 202.1(e), and the required skull-and-crossbones

warning on bottles of poison is not unconstitutional because it is intended to deter

inappropriate use, see 16 C.F.R. § 1500.14. On the contrary, the evidence on which

the FDA relied demonstrates that the “salience” of graphic warnings is critical to

the warnings’ effectiveness. 76 Fed. Reg. at 36,697-98; see IOM Report at C-3. As

the agency explained, the “overall body of scientific literature indicates that health

warnings that evoke strong emotional reactions enhance an individual’s ability to

25

process the warning information.” 76 Fed. Reg. at 36,641. By “eliciting strong

emotional and cognitive reactions,” the warnings “enhance[] recall and information

processing, which helps to ensure that the warning is better processed, understood

and remembered,” and increases understanding of “the extent to which an

individual could personally experience a smoking-related disease.” Id. at 36,641,

36,642.

The district court focused on the warnings’ inclusion of the national quitline,

1-800-QUIT-NOW, as an example of prohibited “advocacy.” App. 35 n.28. A

phone number, however, is not a form of advocacy; it is information for consumers

about the availability of assistance to help them quit. Strong scientific evidence

demonstrates the value of providing this information. As the Institute of Medicine

found, quitlines have proved “effective … in helping individuals to stop

smoking”—increasing smoking abstinence by as much as 30 to 50%. IOM Report

at 237. The U.S. Public Health Service similarly concluded that smokers who use

telephone quitlines are significantly more successful at quitting than those who get

little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines,

Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).10 These

conclusions are consistent with well-established evidence confirming that by

10 Available at http://www.surgeongeneral.gov/tobacco/treating_tobacco_

use08.pdf.

26

providing a direct and immediate cue for action, quitlines significantly increase the

likelihood of changes in behavior. See, e.g., Abrams, Boosting Population Quits

Through Evidence-Based Cessation Treatment and Policy, 38 Am. J. Preventative

Med. Supp. S351 (2010).

In addition to the quitline, each of the graphic warnings provides undisputed

factual information about the health risks of smoking:

A. “Smoking can kill you.”

To illustrate the warning “smoking can kill you,” the FDA chose an image

of a body on an autopsy table. The image truthfully illustrates the uniquely

dangerous nature of cigarettes, which, unlike any other consumer product, kill up

to half of the people who use them as they are intended to be used. WHO Report at

8; President’s Cancer Panel Report at 61. Tobacco kills an estimated 443,000

people in the United States every year—more “than AIDS, alcohol, illegal drug

use, homicide, suicide, and motor vehicle crashes combined.” 75 Fed. Reg. at

69,526.

The district court did not question these well-established facts, instead

criticizing the government for failing to introduce “evidence that smoking causes

autopsies.” App. 28-29 n.18. But whether smokers receive autopsies after they die

is not material to the message conveyed by the warning—that smoking causes

death. Given that cigarettes are the leading cause of preventable death in the

27

United States, plaintiffs cannot dispute that the image of a corpse depicts “a

realistic outcome of the negative health consequences caused by smoking.” 76 Fed.

Reg. at 36,655.

B. “Cigarettes are addictive.”

The graphic illustrating the statement “cigarettes are addictive” shows a man

holding a cigarette and blowing smoke from a tracheostomy hole in his throat.

Doctors use tracheostomies to relieve obstructions of the airway caused by cancer

of the larynx, pharynx, or esophagus—all of which are caused by smoking.

Surgeon General’s Report, The Health Consequences of Smoking 62-67 (2004).11

The image graphically conveys a well-documented fact about cigarettes—they are

so addictive that many smokers are unable to break the habit even after undergoing

surgery for a smoking-related illness. See, e.g., Cooley, Smoking Cessation Is

Challenging Even for Patients Recovering from Lung Cancer Surgery With

Curative Intent, 66 Lung Cancer 218 (Nov. 2009); Walker, Smoking Relapse

During the First Year After Treatment for Early-Stage Non-Small-Cell Lung

Cancer, 15 Cancer Epidemiology Biomarkers & Prevention 2370, 2370 (2006).

C. “Tobacco smoke can harm your children.”

The graphic warning the FDA chose to illustrate the statement “tobacco

smoke can harm your children” depicts a man smoking while holding a baby. This

11 Available at http://www.cdc.gov/tobacco/data_statistics/sgr/2004/index.htm.

28

warning visually conveys the risks of secondhand smoke on children. Exposure to

secondhand smoke harms children by causing sudden infant death syndrome, slow

lung growth, respiratory infections, ear problems, and asthma attacks, among other

problems. Surgeon General’s Report, The Health Consequences of Involuntary

Exposure to Tobacco Smoke 13-14 (2006).12

D. “Smoking during pregnancy can harm your baby.”

The FDA chose a cartoon image of a baby in an incubator to illustrate the

warning “smoking during pregnancy can harm your baby.” Again, the image

accurately illustrates the text of the warning and depicts a realistic consequence of

smoking. Smoking “causes poor birth outcomes such as prematurity, low birth

weight, [and] respiratory problems in the newborn,” among other problems. IOM

Report at 29; Surgeon General’s Report (2006) at 13-14. As the graphic suggests,

an incubator is a common form of treatment for babies born with these kinds of

problems. Tobacco use is also responsible for other serious complications,

resulting in 1,900 to 4,800 infant deaths from perinatal or pre-birth disorders and

1,200 to 2,200 deaths from sudden infant death syndrome. See DiFranza, Effect of

Maternal Cigarette Smoking on Pregnancy Complications and Sudden Infant

Death Syndrome, 40 J. Family Practice 385, 385 (1995).

12 Available at http://www.cdc.gov/tobacco/data_statistics/sgr/2006/index.

htm.

29

E. “Cigarettes cause cancer.”

The warning “cigarettes cause cancer” is illustrated by an image of oral

cancer. According to the Centers for Disease Control and Prevention, smoking is

the primary risk factor for approximately 75% of oral cancer cases in the United

States. CDC, Preventing and Controlling Oral and Pharyngeal Cancer (August

1998).13 The warning communicates a risk of smoking of which many smokers and

potential smokers are unaware. Although most young people know that cigarettes

cause lung cancer, they typically do not understand the risk of other forms of

cancer, including oral cancer. See Weinstein, Public Understanding of the Illnesses

Caused by Cigarette Smoking, 6 Nicotine & Tobacco Res. at 352.

F. “Cigarettes cause fatal lung disease.”

The warning “cigarettes cause fatal lung disease” is illustrated by the side-

by-side images of diseased and healthy lungs. The images truthfully illustrate the

risk of lung cancer, emphysema, and a variety of other lung diseases caused by

smoking. See Surgeon General’s Report (2004) at 61, 508. Indeed, the warning

closely resembles images in the Surgeon General’s 2010 report illustrating the

effects of emphysema caused by smoking. Surgeon General’s Report, How

13 Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00054567.

htm.

30

Tobacco Smoke Causes Disease 449 (2010).14 Overall, nearly 129,000 people in

the United States die each year from smoking-related lung and bronchial cancer.

CDC, Smoking-Attributable Mortality, Years of Potential Life Lost, and

Productivity Losses–United States, 2000-2004 (2008).15 Smoking increases the risk

of death from emphysema and bronchitis by a factor of 10, and the risk of death

from lung cancer by a factor of 22 among men and a factor of nearly 12 among

women. CDC, Tobacco-Related Mortality.16 Among youth, smoking causes health

effects even before it becomes a lifelong habit, including respiratory symptoms,

reduced physical fitness, and stunted lung growth. President’s Cancer Panel Report

at 64.

G. “Cigarettes cause strokes and heart disease.”

The warning “cigarettes cause strokes and heart disease” is illustrated by the

depiction of a patient wearing an oxygen mask—a common treatment for heart

disease. There is no question that smoking dramatically increases the risk of both

heart disease and stroke. See Surgeon General’s Report (2004) at 26-27, 363-419.

14 Available at http://www.surgeongeneral.gov/library/tobaccosmoke/report/

full_report.pdf. 15 Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.

htm. 16 Available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/

health_effects/tobacco_related_mortality/index.htm.

31

Smoking triples the risk of death from heart disease among middle-aged men and

women. CDC, Tobacco-Related Mortality.

H. “Tobacco smoke causes fatal lung disease in nonsmokers.”

The FDA illustrated the warning “tobacco smoke causes fatal lung disease in

nonsmokers” with the image of a woman crying, illustrating the societal and

emotional costs of secondhand smoke. Exposure to secondhand smoke increases

the risk of developing lung cancer by 20 to 30%. CDC, Health Effects of

Secondhand Smoke.17 The pain of losing a loved one, and the suffering from

smoking-induced illnesses, are part of smoking’s real consequences, but “[s]urveys

have demonstrated that individuals have little knowledge of the reality of the pain,

suffering and despair” caused by tobacco use. Philip Morris, 449 F. Supp. 2d at

578. There is nothing misleading about depicting those consequences.

I. “Quitting smoking now greatly reduces serious risks to your health.”

The final graphic warning depicts a man wearing a tee-shirt with the words

“I quit” and the image of a crossed-out cigarette. Nobody—including the

plaintiffs—disputes that quitting greatly reduces health risks. As the Surgeon

General concluded, “quitting smoking has immediate as well as long-term benefits,

reducing risks for diseases caused by smoking and improving health in general.”

17 Available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/

secondhand_smoke/health_effects/index.htm.

32

Surgeon General’s Report (2004) at 25. Indeed, the major tobacco companies make

almost identical statements on their own websites.18

* * *

In sum, each of the graphic warnings illustrates a well-documented health

consequence of smoking in an easy-to-understand and memorable way. The

graphics thus fulfill the purpose of the warnings: “to increase consumer knowledge

and understanding of the health risks of smoking.” 76 Fed. Reg. at 36,642.

CONCLUSION

The district court’s decision granting a preliminary injunction should be

reversed.

Respectfully submitted, /s/Gregory A. Beck Gregory A. Beck Allison M. Zieve Public Citizen Litigation Group 1600 20th Street NW Washington, DC 20009 202-588-1000 Attorneys for amici curiae American Academy of

December 19, 2011 Pediatrics, et al.

18 For example, Lorillard’s website states: “Although quitting smoking can

be very difficult, smokers who want to quit should try to do so. Quitting greatly reduces the health effects of cigarette smoking.” http://www.lorillard.com/responsibility/smoking-and-health/. Similarly, R.J. Reynolds’s website states: “Quitting cigarette smoking significantly reduces the risk for serious diseases.” http://www.rjrt.com/prinbeliefs.aspx.

CERTIFICATE OF COMPLIANCE WITH FEDERAL RULE OF APPELLATE PROCEDURE 32(a)(7)(B)

I certify that this brief complies with the type-face and volume limitations

set forth in Federal Rule of Appellate Procedure 32(a)(7)(B) as follows: the type

face is fourteen-point Times New Roman font, and the word count is 6,900.

/s/Gregory A. Beck

Gregory A. Beck

CERTIFICATE OF SERVICE

I certify that on December 19, 2011, I caused the foregoing to be filed

through the Court’s ECF system, which will serve notice of the filing on counsel

for all parties.

/s/Gregory A. Beck

Gregory A. Beck